Table 2 Primary and secondary outcome measures for all participants; weeks 0–26
Evaluations | Enrollment | Randomization and interventions’ start | Follow-ups | |
|---|---|---|---|---|
Week 0 | Week 1 | Week 12 | Week 26 | |
Primary outcome: depression | ||||
 HRSD-17 | ✓ | ✓ | ✓ | |
Secondary outcome: executive function | ||||
 WAIS-IV–Digit Span | ✓ | ✓ | ✓ | |
 D-KEFS Verbal Fluency Test | ✓ | ✓ | ✓ | |
 California Verbal Learning Test-II, Short form | ✓ | ✓ | ✓ | |
 Rey-Osterrieth Complex Figure–Copy Trial | ✓ | ✓ | ✓ | |
 D-KEFS Color Word Test Conditions 1–3 | ✓ | ✓ | ✓ | |
Exploratory and screening measures: | ||||
 To be administered by examiner: | ||||
  MINI-COG | ✓ | |||
  PHQ-9 | ✓ | ✓ | ✓ | |
  ATHF | ✓ | |||
  Mini International Neuropsychiatric Interview | ✓ | |||
  CIRS-G | ✓ | |||
  CGI (Severity portion only) | ✓ | |||
  CGI (entire scale) | ✓ | ✓ | ||
  Athens Insomnia Scale | ✓ | ✓ | ✓ | |
  MoCA (London only) | ✓ | ✓ | ||
  WAIS-IV–Test of premorbid functioning | ✓ | |||
 To be completed by participant: | ||||
  FES-I (London only) | ✓ | ✓ | ✓ | |
  PHQ-9 | ✓ | ✓ | ✓ | |
  GAD-7 | ✓ | ✓ | ✓ | |
  GAI | ✓ | ✓ | ✓ | |
  WHO DAS 2.0 | ✓ | ✓ | ✓ | |
  EQ-5D-5 L | ✓ | ✓ | ✓ | |
  TTO | ✓ | ✓ | ✓ | |
  TSES | ✓ | ✓ | ✓ | |
  PCI | ✓ | ✓ | ||
  SPWB | ✓ | ✓ | ✓ | |
  FFMQ | ✓ | ✓ | ✓ | |
  Likert scale | ✓ | |||
  Participant-reported side effects | ✓ | ✓ | ||
 Other data collected: | ||||
  Assessment of eligibility | ✓ | |||
  Informed consent | ✓ | |||
  rs-fMRI/MRI/sMRI (only if enrolled in MRI sub-study) | ✓ | ✓ | ||
  Demographics (including medications) | ✓ | |||
  Changes in demographics (including medications) | ✓ | ✓ | ||
  Acti-watcha (Montreal only) | ✓ | ✓ | ||
  Gait (London only) | ✓ | ✓ | ✓ | |
  Blood draw (London only) | ✓ | ✓ | ||